Methotrexate is critical to the treatment of children with acute lymphoblastic leukemia [ALL].
A severe shortage of a childhood cancer drug should ease before hospitals run out of it in a couple weeks, a top federal regulator said Tuesday. But the companies that make the drug are giving few details about how they will find a long-term solution to end the problem.
Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program, said her team is working with the three makers of preservative-free methotrexate, which is used to treat the most common childhood cancer, acute lymphoblastic leukemia, or ALL.
The three manufacturers of the drug — Mylan Inc., Hospira Inc. and Sandoz Inc. — weren't specific about how they plan to resolve the shortage of the cancer medicine:
—Mylan says it's working on increasing manufacturing capacity, which includes getting approval for that from the FDA. The company has an emergency supply of small vials of methotrexate, and plans to ship larger vials at the end of the month.
—Hospira temporarily boosted production to address the shortage issue, but then ran out of the active ingredient. It is still producing some of the drug, but is trying to get more of the active ingredient.
—Sandoz is aiming to ship some of the drug in late February. The company did not provide any details.
CBS News.com Feb. 14, 2012
Medscape.com
Chicago Sun Times
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